NCT01484171Unknown3 期
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete remission
研究概览
简要总结
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent
- •Diagnosis was based on the French-American-British (FAB) and WHO criteria.
- •Age ≥ 7 years old
- •Age < 60 years old
排除标准
- •1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
研究组 & 干预措施
idarubicin
Active Comparator
The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
干预措施: idarubicin (Drug)
microtransplantation
Experimental
The patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells
干预措施: microtransplantation (Biological)
结局指标
主要结局
complete remission
时间窗: one year
次要结局
- overall survival(three years)
- disease-free survival(three years)
研究者
研究点 (1)
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